An open label, balanced, randomized, two-treatment, two period, two-sequence, single oral dose, crossover, bioequivalence study of Nitrocontin Controlled Release tablet 2.6 mg (Nitroglycerin) of Modi-Mundi Pharma Pvt. Ltd., in comparison with Nitromint® Retard Controlled Release tablet 2.6 mg (Nitroglycerin) of M/s Egis Pharma, Hungary in healthy, adult, human subjects under fasting condition. - NI

Modi-Mundi Pharma Pvt. Ltd.0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年9月18日

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•1 Able to comprehend the nature and purpose of the study and willing to give written informed consent for participation in the study
•2 Willing to be available for the entire study period and to comply with protocol requirements
•3 Normal healthy adult human subject of 18 45 years both inclusive of age
•4 Body mass index in the range of 18 30 kg m2 both inclusive and weight at least 50kg
•5 Healthy volunteers who are clinically non anemic will be included as per the discretion of PI CI Physician

•1 Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or blood forming organs
•2 History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past
•3 History of severe infection or major surgery in the past 6 months
•4 History of Minor surgery or fracture within the past 3 months
•5 Significant history or current evidence of malignancy or chronic infectious cardiovascular renal hepatic ophthalmic pulmonary neurological metabolic endocrine hematological gastrointestinal
•immunological or psychiatric diseases or organ dysfunction

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